Maryland Board of Pharmacy Public Board Meeting Meeting ... · inpatient pharmacy as well as an...
Transcript of Maryland Board of Pharmacy Public Board Meeting Meeting ... · inpatient pharmacy as well as an...
Maryland Board of Pharmacy
Public Board Meeting
Meeting Minutes
November 20, 2019
Name Title Present Absent Ashby, D. Commissioner
Bouyoukas, S. Commissioner X
Evans, K. Commissioner
Hardesty, J. Commissioner/Treasurer
Leikach, N. Commissioner
Morgan, K. Commissioner/President
Oliver, B. Commissioner
Rusinko, K. Commissioner/Secretary
Singal, S. Commissioner
Yankellow, E. Commissioner X
Bethman, L. Board Counsel
Felter, B. Staff Attorney
Speights-Napata, D. Executive Director
Fields, E. Deputy Director of Operations
James, D. Licensing Manager
Leak, T. Compliance Director
Clark, B. Legislative Liaison
Chew, C. Management Associate
Subject Responsible
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I. Executive
Committee
Report(s)
A.) K. Morgan,
Board President
B.) K. Rusinko,
Secretary
Members of the Board with a conflict of interest
relating to any item on the agenda are advised to
notify the Board at this time or when the issue is
addressed in the agenda.
1. Call to Order 9:32 am
2. Sign-in Introduction and of meeting
attendees – (Please indicate on sign-in sheet
if you are requesting CE Units for
attendance)
3. Distribution of Agenda and packet
materials
4. Review and approve October 2019 Public
Meeting Minutes
Motion by D. Ashby approval of
October 2019 Public Meeting
minutes; 2nd by N. Leikach
The Board voted to approve
this motion.
II. A. Executive
Director Report
D. Speights-
Napata,
Executive
Director
1. Pharmacy School Intern-Sandra
Nzounkwelle
2. New Board Commissioner-Surinder
Singal
3. MSHP Fall Seminar
1. Deena Speights-Napata
introduced Sandra
Nzounkwelle intern from
UMES.
2. Deena Speights-Napata
introduced incoming
Commissioner Surinder
Singal to the Board.
3. Deena Speights-Napata
attended the MSHP Fall
Seminar and conducted a
presentation to the
leadership group
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4. Board Holiday Closures-Nov. 28th and
29th
highlighting the work the
Board is doing, and
upcoming meetings for
2020.
4. In observance of
Thanksgiving and
American Indian
Heritage day; the Board
office will be closed
November 28 and 29.
B. Operations
Report
E. Fields,
Deputy Director/
Operations
1. Procurement and Budget Updates
a: October 2019 Financial Statements
b: Fine income YTD collected is
$90,000 vs $141,850 collected for FY
2019
2. Management Information Systems (MIS)
Unit Updates
1a. A report on board revenue for
October was provided.
1b. Compliance fines collected
this month is above average.
2. Inspectors will be provided
with new laptops to perform
inspections in a timely manner.
C. Licensing D. James,
Licensing
Manager
1. Unit Updates
2. Monthly Statistics
License
Type
New Renewed Reinstated Total
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Distributor 19 13 0 1,345
Pharmacy 9 0 0 2,048
Pharmacist 86 506 0 13,397
Vaccination 63 155 0 4,884
Pharmacy
Intern -
Graduates
4 0 0 51
Pharmacy
Intern -
Students
15 17 0 779
Pharmacy
Technician
104 357 3 10,007
Pharmacy
Technician
Student
3 0 0 29
TOTAL 303 1,048 3 31,623
D. Compliance T. Leak,
Compliance
Director
1. Unit Updates
2. Monthly Statistics
Complaints & Investigations:
New Complaints –34
Customer Service -5
Employee Pilferage – 1
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Disciplinary Action in Another State –3
Refusal to Fill –1
Unprofessional Conduct – 4
Fraud– 1
Medication Error – 4
Unlicensed Personnel – 2
Dispensing Error – 4
Child Support – 2
Inspection Issues –7
Resolved (Including Carryover) – 28
Actions within Goad – 28/28
Final disciplinary actions taken –10
Summary Actions Taken –0
Average days to complete –0
Inspections:
Total – 157
Annual Inspections – 140
Opening Inspections – 4
Closing inspections – 7
Relocation/Change of Ownership Inspections – 2
Board Special Investigation Inspections – 4
E. Legislation &
Regulations
B. Clark,
Legislative
Liaison
Health Occupations 12-504 Amendment
Amendments to the generic substitution statute have
been proposed by the Board. We are currently
working through the bill with DLS. DLS has made
some minor linguistic changes, but the substance of
the bill remains fully intact.
PDMP Statute
Statutory amendments are being introduced that
would give PDMP the authority to refer cases to
OCSA when it finds evidence that there may be a
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violation of law or professional standards. As part of
the process, the Board and other stakeholders have
been asked to provide input on issues that PDMP may
be able to identify through its data for reporting.
III. Committee
Reports
A. Practice
Committee
J. Hardesty,
Commissioner
Sherry Gregor – America’s Pharmacy Source: I
am wondering what the proper protocol is for a
pharmacist to change a patient prescription
(maintenance medication) refill from a 12 month/30
quantity supply to a 4 month/90 quantity supply
Proposed response: Under Health Occupations
Article § 12-512(c)(2), a pharmacist may dispense up
to a 90-day supply of a prescription drug pursuant to
refills written by an authorized provider, provided
that 1) the pharmacist is not dispensing an initial fill
of the prescription or a change in the prescription; and
2) the drug being dispensed is not a controlled
substance.
Tyika Bassagou – Applicant #121454: There was a
question with no right answer.
What is permissible to delegate to a pharmacy
technician?
- Transferring non-controlled substance prescription
- Transferred non- controlled substance prescription
- Accepting new Prescription
- Independently compounding
The Law says that that a technician cannot do all this.
I thing the right answer might be "accepting new
prescription at a drop off window"
Proposed response: Assuming that either A or B
referred to controlled substances rather than non-
controlled, then the answer referencing the transfer of
a controlled substance prescription would be the
correct response. (COMAR 10.34.34.03)
Recommendation by Committee
to approve draft response; 2nd by
D. Ashby.
Recommendation by Committee
to approve draft 2nd by B. Oliver.
The Board voted to approve
this motion.
The Board voted to approve
this motion.
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Joshua Ryan – MedStar Franklin Square Medical
Center: Franklin Square Medical Center operates an
inpatient pharmacy as well as an outpatient oncology
infusion physician practice in Bel Air, MD. As there
is no pharmacy at the Bel Air Office, we would like
to have pharmacists from Franklin Square review
orders and make modifications to orders/labels after
consulting with physicians. In the EMR this will list
them as the dispensing pharmacist even though they
are not physically present to dispense. We were
going to outline in a policy what the term “dispensed
by” meant at this site to reflect appropriate practice. I
look forward to hearing back if we can begin having
our pharmacist remote review physician orders for an
offsite clinic. Karla Evans Recused
Proposed response: A pharmacist can participate in
this manner provided that it’s a clinical review and
not a review of the final product. In addition, records
should reflect the health care provider who actually
prepared the product.
Laura Pone – Benesch Friedlander Coplan &
Aronoff LLP: Is a chart order from a long term care
facility considered a valid order for the purpose of
dispensing discharge medications to patients that are
ready to be discharged?
Proposed response: Provided that all labeling
requirements are met and all necessary elements (e.g.
quantity) are contained in the chart order, then the
chart order would be a valid order for the purpose for
dispensing discharge medication.
Ayman Ness: My question is are we still should not
exceed the 5 percent??
Recommendation by Committee
to approve draft response; 2nd by
B. Oliver.
Recommendation by Committee
to approve draft response 2nd by
B. Oliver.
The Board voted to approve
this motion.
The Board voted to approve
this motion.
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To be very clear, we order and sell to other places on
small scale, so we order from Amerisource or
McKesson and send to other places
including government. Should we still follow the
5%?
Kindly please let me know if our registration as a
distributor is enough.
Any other conditions that we have to consider or any
other important notes related to the distribution and
we are not considering CONTROLLED items in my
question as we don’t work on it.
Proposed response: If you are distributing under
your distributor permit, the 5% rule does not apply.
The “5% rule” contained in Health Occupations
Article § 12-6C-01(v) (2) (xii) only applies to
pharmacies that are engaging in wholesale
distribution; it does not apply to duly permitted
wholesale distributors.
Raymond Lake – MedStar Health Inc: From a
BOP perspective, what are your thoughts on whether
we can implement IV Prep at Bel Air, which is a non-
Pharmacy Oncology clinic, with remote checking to
be done by Pharmacists in the Loch Raven facility
managed by MFSMC? Presently, a Med Tech and
Nurse prepare/check oncology and non-oncology
sterile admixtures at Bel Air. Will this require
writing a letter to the MD BOP asking for permission
to use this technology as I’ve indicated? Karla Evans
Recused
Proposed response: A pharmacist can participate in
this manner provided that it’s a clinical review and
not a review of the final product. In addition, the
record should reflect the health care provider who
actually prepared the product.
Recommendation by Committee
to approve draft response 2nd by
D. Ashby.
Tabled until December meeting
The Board voted to approve
this motion.
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Any questions regarding med techs for med techs
should be directed to the Maryland Board of Nursing.
Shirish Patil – Chase Brexton Health Care: At
our Healthcare Center, we have a Medication Support
Team (MST) that prepares weekly/bi-weekly pill
boxes for patients that are either challenged or
incapable of organizing and preparing their own daily
medication regimen.
The patient specific medication supplies used in
preparation of these pill boxes are prepared in
our regular Pharmacy and accuracy verified by a
pharmacist per standard pharmacy practice. The pill
boxes are then prepared in the MST medication
room by a certified pharmacy technician.
We have the following two questions in regards to
checking of these pill boxes prior to dispensation to a
patient:
1) Can these filled pill boxes be checked by a licensed
nurse?
2) Can these pill boxes be checked by another
certified pharmacy technician?
Proposed response: Once the medication has been
dispensed to the patient or patient’s agent (the
“MST”), any further manipulation of the packaging is
not under the purview of the Maryland Board of
Pharmacy. It is permissible for a pharmacy technician
to perform this check, but it should be noted that
because the medication is considered to be dispensed
once it is handed over to the MST, the technician
Motion by Committee to approve
draft response 2nd by B. Oliver.
The Board voted to approve
this motion.
Subject Responsible
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Discussion
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would not be performing a designated pharmacy act
in this scenario.
Your question regarding whether a nurse may check
pill boxes should be directed to the Maryland Board
of Nursing, as this is a question regarding a nurse’s
scope of practice.
Sarah Benner: I'm the psychiatric clinical pharmacist
at PRMC in Salisbury. I'm emailing for clarification
regarding pharmacist scope of practice regarding
administration of IM non-vaccinations on hospital
grounds for non-inpatients.
Proposed response: Pharmacists are currently only
permitted to administer vaccinations pursuant to Md.
Code Ann., Health Occ. § 12-508 and self-
administered drugs pursuant to Md. Code Ann.,
Health Occ. § 12-509. Pharmacists thus may not
administer non-vaccination IM injections, except to
the extent that they are self-administered drugs as
defined under Md. Code Ann., Health Occ. § 12-509.
Recommendation by Committee
to approve draft response; 2nd by
B. Oliver.
The Board voted to approve
this motion.
B. Licensing
Committee
D. Ashby, Chair 1. Review of Pharmacist Applications:
a. #120685- The applicant is requesting ADA
Testing accommodation for the MPJE and
NAPLEX exams. He is requesting an
additional two hours for both exams. The
applicant has test anxiety agitation, and poor
concentration. (Regular exam time is four
hours long)
Committee’s recommendation: Approve
b. #123463- The applicant is requesting ADA
Testing accommodation for the MPJE and
NAPLEX exams. She would like an
1a. Recommendation by
Committee to approve 2
additional hours of exam testing;
2nd by J. Hardesty.
1b. Recommendation by
Committee to approve 4
The Board voted to approve
this motion.
The Board voted to approve
this motion.
Subject Responsible
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Discussion
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additional 4 hours, reduced distraction, and
written text exams. The applicant’s diagnosis
of her disability are anxiety, panic attacks,
and other physiological arousal, ADHD with
insufficient symptoms of inattention and
hyperactivity. (Regular exam time is four
hours long)
Committee’s recommendation: Approve
c. #119576- The applicant is requesting an
additional 1.5 hours for his ADA Testing
accommodations for the MPJE exam. The
applicant has been diagnosed with ADD.
(Regular exam time is four hours long)
Committee’s recommendation: Approve
d. #118757- The applicant is requesting a
four-month extension of his NAPLEX ATT
eligibility date and MDBOP application. The
applicant was granted his ATT eligibility on
10/10/2018, which he never utilized. This is
his first eligibility date extension request
addressing the Board.
Committee’s recommendation: Approve
e. MB- Pharmacist MB request for refund
was denied at the September 2019 Board
meeting. He is requesting reconsideration.
He has not provided additional information.
Committee’s Recommendation: Deny
f. HU- Pharmacist HU is requesting a waiver
of the reinstatement process. He renewed
online 08/28/2019, and answered ‘no” to
question # 11, Have you completed the
required CE? An email was sent on
additional hours of exam testing;
2nd by N. Leikach.
1c. Recommendation by
Committee to approve 1.5
additional hours of exam testing;
2nd by K. Rusinko.
1d. Recommendation by
Committee to approve eligibility
date extension and MDBOP
application; 2nd by B. Oliver.
1e. Recommendation by
Committee to deny refund; 2nd by
B. Oliver.
1f. Recommendation by
Committee to deny waiver of
reinstatement process; 2nd by B.
Oliver.
The Board voted to approve
this motion.
The Board voted to approve
this motion.
The Board voted to approve
this motion.
The Board voted to approve
this motion.
Subject Responsible
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Discussion
Action Due Date
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08/29/2019 requesting proof of CE’s, no
response was received.
Committee’s Recommendation: Deny
2. Review of Pharmacy Intern Applications:
NONE
3. Review of Pharmacy Technician Applications:
NONE
4. Review of Distributor Applications: NONE
5. Review of Pharmacy Applications: NONE
6. Review of Pharmacy Technicians Training
Programs: NONE
7. Continuing Education Hours Requests:
a. Ashley Rzepinnik - Ms. Rzepinnik
requests the denial of the CE request be
reconsidered. Her request for
reconsideration is based on the fact that
for the past 5 years the same program has
been approved and that the program has
not changed. DAN ASHBY AND KRIS
RUSINKO RECUSED Committee’s
Recommendation: Approve for 2 hours.
b. Carlita Kearney - Ms. Kearney would
like the reason/reconsideration for denial
of the CE program. DAN ASHBY AND
KRIS RUSINKO RECUSED
Committee’s Recommendation: Approve
for 7 hours.
7a. Recommendation by
Committee to approve 2 hours;
2nd by N. Leikach.
7b. Recommendation by
Committee to approve 7 hours;
2nd by K. Evans.
The Board voted to approve
this motion.
The Board voted to approve
this motion.
Subject Responsible
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Discussion
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c. Ali Dalili- Requesting CE approval as an
attendee. Committee’s Recommendation:
Deny
d. Hye Jin Pak - Requesting CE approval as
an attendee.
Committee’s Recommendation: Approve
for 1.5 hours
8. New Business:
a. Healix Infusion Therapy LLC - At the
September 2019 Board meeting a 30-day
extension was granted to allow for
operations at the company’s new facility
while awaiting VAWD inspection. Due
to delays the company is requesting
additional time. The company is
requesting a 60-day extension.
Committee’s Recommendation: Approve
b. CRX Specialty Solutions Pharmacy -Is
requesting an extension to the 60 day
Maryland Pharmacist replacement. The
future MD pharmacist, John Sullivan is
pending Committee and Board review.
The previous MD Pharmacist (Steven
Boyd) resigned effective 09/15/2019.
Committee’s Recommendation: Approve
c. Y.A.- Registrant YA is requesting the
hours earned as a technician to be used as
intern hours. She held a technician
registration from 04/28/2016 to
03/28/2019. Her intern registration was
issued 03/28/2019. Hours earned as a
7c. Recommendation by
Committee to deny; 2nd by K.
Evans.
7d. Recommendation by
Committee to approve 1. 5 CE
hours; 2nd by N. Leikach.
8a. Recommendation by
Committee to approve; 2nd by K.
Evans.
8b. Recommendation by
Committee to approve; 2nd by K.
Evans.
8c. Recommendation by
Committee to deny; 2nd by N.
Leikach.
The Board voted to approve
this motion.
The Board voted to approve
this motion.
The Board voted to approve
this motion.
The Board voted to approve
this motion.
The Board voted to approve
this motion.
Subject Responsible
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Discussion
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technician can be counted towards intern
hours if accrued on or before 10/01/2015.
Committee’s Recommendation: Deny
C. Public
Relations
Committee
D. Ashby,
Commissioner
Public Relations Committee Update:
CE Breakfast recap-positive feedback
received from the October event. All CE’s
were uploaded to each attendees account.
Future newsletter timeline and discussion
on other communication strategies to
reach pharmacist and technicians.
Representation from Board members and
staff to attend other pharmacy association
events were also discussed.
D. Disciplinary J. Hardesty
Chair
Disciplinary Committee Update:
Committee met November 6.
A confidential discussion will be held in the
Board’s Closed Public Session.
E. Emergency
Preparedness
Task Force
N. Leikach,
Chair
Emergency Preparedness Task Force Update:
A 3-hour Point of Distribution exercise was
held at Notre Dame on November 5,
during that exercise 40 students signed up
to be volunteers.
A 2-hour lecture was held at University of
Maryland Baltimore on emergency
preparedness.
Subject Responsible
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Discussion
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IV. Other
Business & FYI
K. Morgan,
President
1. Commissioner overnight stipend
compensation—increase $250—Kevin
Morgan
2. Schools of Pharmacy Committee Meeting—
Karla Evans
1. Recommendation by
Executive Committee to change
stipend compensation; 2nd by K.
Evans.
Partnership with Deans to
educate future pharmacist of the
processes and the successfulness
of MPJE exam through the pre-
test.
The Board voted to approve
this motion.
V. Adjournment K. Morgan,
President
A. The Public Meeting was adjourned at 10:39
am.
B. K. Morgan convened a Closed Public Session
to conduct a medical review committee
evaluation of confidential applications.
C. The Closed Public Session was adjourned.
Immediately thereafter, K. Morgan, convened
an Administrative Session for purposes of
discussing confidential disciplinary cases.
D. With the exception of cases requiring
recusals, the Board members present at the
Public Meeting continued to participate in the
Closed Public Session and the Administrative
Session
Motion to close the Public Board
Meeting by D. Ashby; 2nd by K.
Evans.
The Board voted to approve
this motion.